Abstract
The most used pharmaceutical formulations for children are syrups, suppositories, soft chewable capsules, and mini-tablets. Administrating them might create an administration discomfort. This study aimed to develop and evaluate orodispersible films (ODFs) for pediatric patients in which the fluoxetine (FX) is formulated in the polymeric matrix. Six FX fast dissolving films (10 mg FX/ODF), FX1, FX2, FX3, FX4, FX5, and FX6, were prepared by solvent casting technique. In the composition of the ODFs, the concentration of the hydroxypropyl methylcellulose and the concentration of the propylene glycol were varied. Each formulation of fluoxetine ODF was evaluated by determining the tensile strength, folding endurance, disintegration, behavior in the controlled humidity and temperature conditions, and adhesiveness. All the obtained results were compared with the results obtained for six ODFs prepared without FX. The disintegration time of the FX ODFs was of maximum 88 s for FX2. Via the in vitro releasing study of the FX from the ODFs it was noticed that FX1 and FX2 allow a better release of the drug 99.98 ± 3.81% and 97.67 ± 3.85% being released within 15 min. From the obtained results it was also confirmed that FX ODFs were found to follow first-order release kinetic.
Highlights
The most pharmaceutical formulations used for children are syrups, suppositories, soft chewable capsules, and mini-tablets [1]
Orodispersible systems represent a new approach of the oral release of the active pharmaceutical ingredients (APIs), by which an increased acceptance rate is assured in virtue of fast dissolution the possibility of self-administrating, without water
orodispersible films (ODFs) are based on a typical composition: API, hydrophilic polymers, plasticizers, fillers, colors and flavors
Summary
The most pharmaceutical formulations used for children are syrups, suppositories, soft chewable capsules, and mini-tablets [1]. Taking into consideration the disadvantages of the conventional pharmaceutical forms and aiming to increase the bioavailability of an active pharmaceutical ingredient (API), orodispersible systems can bring multiple advantages. The oral route represents for most of the patients the preferred route for administration of the conventional pharmaceutical formulations due to the main advantages such as convenience in administration and the noninvasive property. Even though oral administration is the most accepted method for the administration of pharmaceutical ingredients, due to some pathologies such as dysphagia, the deglutition becomes painful [5,6]. Orodispersible systems represent a new approach of the oral release of the active pharmaceutical ingredients (APIs), by which an increased acceptance rate is assured in virtue of fast dissolution the possibility of self-administrating, without water. Reported to the composition of an ODF, the drug can be incorporated until
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